Best practice guide on leachables risk published
12 April 2017 | By Steve Bremer, Managing Editor
The Biophorum Operations Group BPOG has published a best-practices guide for evaluating leachables risk from single-use systems (SUS)...
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FDA approves first drug to treat tardive dyskinesia
12 April 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition. Tardive dyskinesia is a neurological disorder characterised by repetitive involuntary movements, usually of the jaw, lips and tongue, such as…
Lonza to host new webinar: “Justifying a paperless solution – building a compelling business case”
Lonza is hosting a free 60-minute webinar on 25 April 2017 on how to create a compelling business case for the implementation of a paperless QC testing solution.
Therapix signs license with Yissum for cannabinoid nasal drug delivery technology
10 April 2017 | By Niamh Marriott, Junior Editor
Therapix Biosciences has signed a sublicense agreement for Yissum Research Development Company of the Hebrew University nasal drug delivery technology...
Jazz Pharmaceuticals submits FDA application for leukaemia treatment
7 April 2017 | By Niamh Marriott, Junior Editor
Jazz Pharmaceuticals completed a rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of Vyxeos...
BTG receives CE mark certification for radiopaque drug-eluting bead
6 April 2017 | By Niamh Marriott, Junior Editor
BTG has received Class III CE Mark certification for DC Bead LUMI, the first commercially available radiopaque drug-eluting bead...
New drug reduces daily menopausal hot flushes by 73%
6 April 2017 | By Niamh Marriott, Junior Editor
In a trial carried out at Imperial College, researchers showed that women who suffered seven or more hot flushes a day could reduce the number by 73%...
FDA grants Kitov waiver for new drug application filing fee
6 April 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration (FDA) has granted Kitov Pharmaceuticals a waiver related to the $2,038,100 new drug application filing fee for KIT-302...
Novartis’ lung cancer drug combination receives EU approval
5 April 2017 | By Niamh Marriott, Junior Editor
The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat fnon-small cell lung cancer...
New report reveals little progress on 2014 WHO psoriasis recommendations
5 April 2017 | By Niamh Marriott, Junior Editor
A new report by the Economist Intelligence Unit (EIU) reveals governments have taken little or no action to improve care for those living with psoriasis...
Phase II Lymphoma study of Daratumumab will not continue to stage 2
4 April 2017 | By Niamh Marriott, Junior Editor
Janssen Biotech has decided not to initiate stage 2 of the Phase II study of daratumumab in three types of relapsed or refractory non-Hodgkin’s lymphoma...
AstraZeneca lung cancer drug receives FDA approval
4 April 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration (FDA) has granted full approval for AstraZeneca’s Tagrisso (osimertinib) tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR…
IntelliCyt launches novel assay system to accelerate cell line development
3 April 2017 | By IntelliCyt
The IntelliCyt Cy-Clone™ PLUS Assay System will accelerate and improve the quality of clone ranking and selection for developing cell lines which can reduce production costs of biopharmaceuticals...
FDA approves Sanofi and Regeneron’s new eczema drug
The US Food and Drug Administration (FDA) approved Sanofi and Regeneron's Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis).
NICE does not recommend Shire’s pancreatic cancer drug
3 April 2017 | By Niamh Marriott, Junior Editor
The National Institute or Health and Care Excellence (NICE) has published final guidance that does not recommend pegylated liposomal irinotecan (Onivyde, Shire).
